Patent Grant
10589104
The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to systems and methods for generating a stimulation program for electrical stimulation of a patient.
Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients. Stimulation of the brain, such as deep brain stimulation, can be used to treat a variety of diseases or disorders.
Stimulators have been developed to provide therapy for a variety of treatments. A stimulator can include a control module (with a pulse generator), at least one lead, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.
One embodiment is a method for generating a stimulation program for electrical stimulation of a patient. The method includes providing, by a processor on a display communicatively coupled to the processor, a first grid demarcating a plurality of selectable first pixels and a representation of a portion of an electrical stimulation lead with a plurality of electrodes; obtaining, by the processor, a user selection of a first plurality of the first pixels in the first grid of first pixels for stimulation; generating, by the processor, a stimulation program based, at least in part, on the user-selected first plurality of the first pixels for stimulation using at least one of the electrodes of the electrical stimulation lead; and initiating, by the processor, a signal that provides an implantable pulse generator with the stimulation program for producing electrical stimulation using an electrical stimulation lead coupled to the implantable pulse generator in accordance with the stimulation program.
In at least some embodiments, generating the stimulation program includes: determining, by the processor, a target volume based, at least in part, on the user-selected first plurality of the first pixels for stimulation; determining, by the processor, a stimulation field model (SFM) based, at least in part, on the determined target volume; and generating, by the processor, the stimulation program based, at least in part, on the SFM.
In at least some embodiments, the method further includes: providing, by the processor on the display, a second grid demarcating a plurality of selectable second pixels, the second grid of second pixels residing on a different plane than a plane on which the first grid of first pixels resides; and obtaining, by the processor, a user selection of a plurality of the second pixels in the second grid of second pixels for stimulation, wherein determining the target volume includes determining, by the processor, the target volume based, at least in part, on both the user-selected first plurality of the first pixels for stimulation and the user-selected plurality of the second pixels for stimulation.
In at least some embodiments, providing the first grid of first pixels includes providing, by the processor on the display, a view of the first grid of first pixels, wherein the view shows the first grid of first pixels in relation to a representation of at least one anatomical or physiological feature.
In at least some embodiments, the method further includes obtaining, by the processor, a user selection of a second plurality of the first pixels in the first grid of first pixels to avoid stimulation, wherein generating the stimulation program includes: determining, by the processor, a first volume based, at least in part, on the user-selected first plurality of the first pixels for stimulation; determining, by the processor, a second volume based, at least in part, on the user-selected second plurality of the first pixels to avoid stimulation; determining, by the processor, a stimulation field model (SFM) based, at least in part, on the first and second determined volumes; and generating, by the processor, the stimulation program based, at least in part, on the SFM.
In at least some embodiments, generating the stimulation program includes: matching, by the processor, the user-selected first plurality of the first pixels for stimulation to a stimulation field model (SFM) stored in a memory communicatively coupled to the processor; selecting, by the processor, at least one of the electrodes of the electrical stimulation lead based, at least in part, on the SFM; selecting, by the processor, a set of stimulation parameters based, at least in part, on the SFM; and generating, by the processor, the stimulation program.
In at least some embodiments, the method further includes obtaining, by the processor, a user input representing a stimulation level for each one of the user-selected first plurality of the first pixels for stimulation, wherein generating the stimulation program includes generating, by the processor, the stimulation program based, at least in part, on the user-selected first plurality of the first pixels for stimulation and on the user-input stimulation level for each one of the user-selected first plurality of the first pixels for stimulation.
In at least some embodiments, the method further includes superimposing the first grid of first pixels on a representation of at least one anatomical or physiological feature.
Another embodiment is a method for generating a stimulation program for electrical stimulation of a patient. The method includes providing, by processor on a display communicatively coupled to the processor, a portion of a first plane; obtaining, by the processor, a user placement of a first primitive onto the first plane for stimulation; obtaining, by the processor, a user input of a command to modify at least one feature of the user-placed first primitive for stimulation; generating, by the processor, a stimulation program based, at least in part, on the modified user-placed first primitive for stimulation; and initiating, by the processor, a signal that provides an implantable pulse generator with the stimulation program for producing electrical stimulation using an electrical stimulation lead coupled to the implantable pulse generator in accordance with the stimulation program.
In at least some embodiments, generating the stimulation program includes: determining, by the processor, a target volume based, at least in part, on the modified user-placed first primitive for stimulation; determining, by the processor, a stimulation field model (SFM) based, at least in part, on the determined target volume; and generating, by the processor, the stimulation program based, at least in part, on the SFM.
In at least some embodiments, the method further includes providing, by the processor on the display, a portion of a second plane different from the first plane; obtaining, by the processor, a user placement of a second primitive onto the second plane; and obtaining, by the processor, a user input of a command to modify at least one feature of the user-placed second primitive for stimulation, wherein determining the target volume includes determining, by the processor, the target volume based, at least in part, on both the modified user-placed first primitive for stimulation and the modified user-placed second primitive for stimulation.
In at least some embodiments, obtaining the user input of the command to modify the at least one feature of the user-placed first primitive for stimulation includes obtaining, by the processor, a user input of a command to alter a shape of the user-placed first primitive for stimulation along at least one dimension of the user-placed first primitive for stimulation.
In at least some embodiments, the method further includes obtaining, by the processor, a user placement of a second primitive onto the first plane to avoid stimulation, wherein generating the stimulation program includes: determining, by the processor, a first volume based, at least in part, on the modified user-placed first primitive for stimulation; determining, by the processor, a second volume based, at least in part, on the user-placed second primitive to avoid stimulation; determining, by the processor, a stimulation field model (SFM) based, at least in part, on the first and second determined volumes; and generating, by the processor, the stimulation program based, at least in part, on the SFM, wherein the stimulation program, when implemented by the implantable pulse generator, causes the implantable pulse generator to stimulate the first determined volume and to avoid stimulation of the second determined volume.
In at least some embodiments, determining the SFM includes determining when the second determined volume overlaps at least one portion of first determined volume; and generating the stimulation program based, at least in part, on the SFM includes, responsive to the second determined volume overlapping the at least one portion of the first determined volume, generating, by the processor, the stimulation program based, at least in part, on the SFM, wherein the stimulation program, when implemented by the implantable pulse generator, causes the implantable pulse generator to stimulate at least one portion of the first determined volume that the second determined volume fails to overlap and to avoid stimulation of at least one portion of the second determined volume.
In at least some embodiments, the method further includes obtaining, by the processor, a user input of a command to modify at least one feature of the user-placed second primitive to avoid stimulation, wherein determining the second volume includes determining, by the processor, the second volume based, at least in part, on the modified user-placed second primitive to avoid stimulation.
In at least some embodiments, generating the stimulation program includes: matching, by the processor, the modified user-placed first primitive to a stimulation field model (SFM) stored in a memory communicatively coupled to the processor; selecting, by the processor, a set of stimulation electrodes from the electrodes of the electrical stimulation lead based, at least in part, on the SFM; selecting, by the processor, a set of stimulation parameters based, at least in part, on the SFM; and generating, by the processor, the stimulation program, wherein the stimulation program, when implemented by the implantable pulse generator, causes the implantable pulse generator to stimulate the patient via the set of stimulation electrodes according to the set of stimulation parameters.
Yet another embodiment is a non-transitory computer-readable medium having computer executable instructions stored thereon that, when executed by at least one processor, cause the at least one processor to perform any of the methods described above.
A further embodiment is a system for generating a stimulation program for electrical stimulation of a patient, the system including processor configured and arranged to perform any of the methods described above.
Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.
For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:
The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to systems and methods for selecting stimulation parameters.
Suitable implantable electrical stimulation systems include, but are not limited to, a least one lead with at least one electrode disposed on a distal end portion of the lead and at least one terminal disposed on at least one proximal end portion of the lead. Leads include, for example, percutaneous leads, paddle leads, cuff leads, or any other arrangement of electrodes on a lead. Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,244,150; 7,450,997; 7,672,734; 7,761,165; 7,783,359; 7,792,590; 7,809,446; 7,949,395; 7,974,706; 8,175,710; 8,224,450; 8,271,094; 8,295,944; 8,364,278; 8,391,985; and 8,688,235; and U.S. Patent Applications Publication Nos. 2007/0150036; 2009/0187222; 2009/0276021; 2010/0076535; 2010/0268298; 2011/0005069; 2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911; 2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615; 2013/0105071; and 2013/0197602, all of which are incorporated by reference. In the discussion below, a percutaneous lead will be exemplified, but it will be understood that the methods and systems described herein are also applicable to paddle leads and other leads.
A lead for electrical stimulation (for example, deep brain or spinal cord stimulation) includes stimulation electrodes that can be ring electrodes, segmented electrodes that extend only partially around the circumference of the lead, or any other type of electrode, or any combination thereof. The segmented electrodes can be provided in sets of electrodes, with each set having electrodes circumferentially distributed about the lead at a particular longitudinal position or across a particular longitudinal region. For illustrative purposes, the leads are described herein relative to use for deep brain stimulation, but it will be understood that any of the leads can be used for applications other than deep brain stimulation, including spinal cord stimulation, peripheral nerve stimulation, or stimulation of other nerves, muscles, and tissues. In particular, stimulation may stimulate specific targets. Examples of such targets include, but are not limited to, the subthalamic nucleus (STN), internal segment of the globus pallidus (GPi), external segment of the globus pallidus (GPe), and the like. In at least some embodiments, an anatomical structure is defined by its physical structure and a physiological target is defined by its functional attributes. In at least some embodiments, the lead may be positioned at least partially within the target, but in other embodiments, the lead may be near, but not inside, the target. The stimulation of tissue can include, but is not limited to, one or more of activation, inhibition, depression, or other modulation of the stimulated tissue.
Turning to
The IPG 14 is physically connected, optionally via at least one lead extension 24, to the stimulation lead(s) 12. Each lead carries multiple electrodes 26 arranged in an array. The IPG 14 includes pulse generation circuitry that delivers electrical stimulation energy in the form of, for example, a pulsed electrical waveform (i.e., a temporal series of electrical pulses) to the electrode array 26 in accordance with a set of stimulation parameters. The IPG 14 can be implanted into a patient's body, for example, below the patient's clavicle area or within the patient's buttocks or abdominal cavity. The IPG 14 can have eight stimulation channels which may be independently programmable to control the magnitude of the current stimulus from each channel. In at least some embodiments, the IPG 14 can have more or fewer than eight stimulation channels (for example, 4-, 6-, 16-, 32-, or more stimulation channels). The IPG 14 can have one, two, three, four, or more connector ports, for receiving the terminals of the leads.
The ETS 20 may also be physically connected, optionally via the percutaneous lead extensions 28 and external cable 30, to the stimulation leads 12. The ETS 20, which may have similar pulse generation circuitry as the IPG 14, also delivers electrical stimulation energy in the form of, for example, a pulsed electrical waveform to the electrode array 26 in accordance with a set of stimulation parameters. One difference between the ETS 20 and the IPG 14 is that the ETS 20 is often a non-implantable device that is used on a trial basis after the neurostimulation leads 12 have been implanted and prior to implantation of the IPG 14, to test functioning of the system or the responsiveness of the stimulation that is to be provided. Any functions described herein with respect to the IPG 14 can likewise be performed with respect to the ETS 20.
The RC 16 may be used to telemetrically communicate with or control the IPG 14 or ETS 20 via a uni- or bi-directional wireless communications link 32. Once the IPG 14 and neurostimulation leads 12 are implanted, the RC 16 may be used to telemetrically communicate with or control the IPG 14 via a uni- or bi-directional communications link 34. Such communication or control allows the IPG 14 to be turned on or off and to be programmed with different stimulation parameter sets. The IPG 14 may also be operated to modify the programmed stimulation parameters to actively control the characteristics of the electrical stimulation energy output by the IPG 14. The CP 18 allows a user, such as a clinician, the ability to program stimulation parameters for the IPG 14 and ETS 20 in the operating room and in follow-up sessions.
The CP 18 may perform this function by indirectly communicating with the IPG 14 or ETS 20, through the RC 16, via a wireless communications link 36. Alternatively, the CP 18 may directly communicate with the IPG 14 or ETS 20 via a wireless communications link (not shown). The stimulation parameters provided by the CP 18 are also used to program the RC 16, so that the stimulation parameters can be subsequently modified by operation of the RC 16 in a stand-alone mode (i.e., without the assistance of the CP 18).
For purposes of brevity, the details of the RC 16, CP 18, ETS 20, and external charger 22 will not be further described herein. Details of exemplary embodiments of these devices are disclosed in U.S. Pat. No. 6,895,280, which is expressly incorporated herein by reference. Other examples of electrical stimulation systems can be found at U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395; 7,244,150; 7,672,734; and 7,761,165; 7,974,706; 8,175,710; 8,224,450; and 8,364,278; and U.S. Patent Application Publication No. 2007/0150036, as well as the other references cited above, all of which are incorporated by reference.
In at least some embodiments, measurement devices coupled to the muscles or other tissues affected by the target neurons or neural structures, or a unit responsive to the patient or clinician, can be coupled to the IPG 14 or microdrive motor system. The measurement device, user, or clinician can indicate a response by the target muscles or other tissues to the stimulation or recording electrode(s) to further identify the target neurons and facilitate positioning of the stimulation electrode(s). For example, if the target neurons are directed to a muscle experiencing tremors, a measurement device can be used to observe the muscle and indicate changes in, for example, tremor frequency or amplitude in response to stimulation of neurons. Alternatively, the patient or clinician can observe the muscle and provide feedback.
The lead 100 for deep brain stimulation can include stimulation electrodes, recording electrodes, or both. In at least some embodiments, the lead 100 is rotatable so that the stimulation electrodes can be aligned with the target neurons after the neurons have been located using the recording electrodes.
Stimulation electrodes may be disposed on the circumference of the lead 100 to stimulate the target neurons. Stimulation electrodes may be ring shaped so that current projects from each electrode equally in every direction from the position of the electrode along a length of the lead 100. In the embodiment of
The lead 100 includes a lead body 110, terminals 135, at least one ring electrode 120, and at least one set of segmented electrodes 130 (or any other combination of electrodes). The lead body 110 can be formed of a biocompatible, non-conducting material such as, for example, a polymeric material. Suitable polymeric materials include, but are not limited to, silicone, polyurethane, polyurea, polyurethane-urea, polyethylene, or the like. Once implanted in the body, the lead 100 may be in contact with body tissue for extended periods of time. In at least some embodiments, the lead 100 has a cross-sectional diameter of no more than 1.5 mm and may be in the range of 0.5 to 1.5 mm. In at least some embodiments, the lead 100 has a length of at least 10 cm and the length of the lead 100 may be in the range of 10 to 70 cm.
The electrodes 125 can be made using a metal, alloy, conductive oxide, or any other suitable conductive biocompatible material. Examples of suitable materials include, but are not limited to, platinum, platinum iridium alloy, iridium, titanium, tungsten, palladium, palladium rhodium, or the like. Preferably, the electrodes 125 are made of a material that is biocompatible and does not substantially corrode under expected operating conditions in the operating environment for the expected duration of use.
Each of the electrodes 125 can either be used or unused (OFF). When an electrode is used, the electrode can be used as an anode or cathode and carry anodic or cathodic current. In some instances, an electrode might be an anode for a period of time and a cathode for a period of time.
Deep brain stimulation leads may include at least one set of segmented electrodes. Segmented electrodes may provide for superior current steering than ring electrodes because target structures in deep brain stimulation are not typically symmetric about the axis of the distal electrode array. Instead, a target may be located on one side of a plane running through the axis of the lead. Through the use of a radially segmented electrode array (“RSEA”), current steering can be performed not only along a length of the lead but also around a circumference of the lead. This provides precise three-dimensional targeting and delivery of the current stimulus to neural target tissue, while potentially avoiding stimulation of other tissue. Examples of leads with segmented electrodes include U.S. Pat. Nos. 8,473,061; 8,571,665; and 8,792,993; U.S. Patent Application Publications Nos. 2010/0268298; 2011/0005069; 2011/0130803; 2011/0130816; 2011/0130817; 2011/0130818; 2011/0078900; 2011/0238129; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911; 2012/197375; 2012/0203316; 2012/0203320; 2012/0203321; 2013/0197424; 2013/0197602; 2014/0039587; 2014/0353001; 2014/0358208; 2014/0358209; 2014/0358210; 2015/0045864; 2015/0066120; 2015/0018915; 2015/0051681; U.S. patent application Ser. Nos. 14/557,211 and 14/286,797; and U.S. Provisional Patent Application Ser. No. 62/113,291, all of which are incorporated herein by reference.
The computing device 300 can be a computer, tablet, mobile device, or any other suitable device for processing information. The computing device 300 can be local to the user or can include components that are non-local to the computer including one or both of the processor 302 or memory 304 (or portions thereof). For example, in at least some embodiments, the user may operate a terminal that is connected to a non-local computing device. In other embodiments, the memory can be non-local to the user.
The computing device 300 can utilize any suitable processor 302 including at least one hardware processors that may be local to the user or non-local to the user or other components of the computing device. The processor 302 is configured to execute instructions provided to the processor 302, as described below.
Any suitable memory 304 can be used for the computing device 302. The memory 304 illustrates a type of computer-readable media, namely computer-readable storage media. Computer-readable storage media may include, but is not limited to, nonvolatile, non-transitory, removable, and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computer-readable storage media include RAM, ROM, EEPROM, flash memory, or other memory technology, CD-ROM, digital versatile disks (“DVD”) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a computing device.
Communication methods provide another type of computer readable media; namely communication media. Communication media typically embodies computer-readable instructions, data structures, program modules, or other data in a modulated data signal such as a carrier wave, data signal, or other transport mechanism and include any information delivery media. The terms “modulated data signal,” and “carrier-wave signal” includes a signal that has at least one of its characteristics set or changed in such a manner as to encode information, instructions, data, and the like, in the signal. By way of example, communication media includes wired media such as twisted pair, coaxial cable, fiber optics, wave guides, and other wired media and wireless media such as acoustic, RF, infrared, and other wireless media.
The display 306 can be any suitable display device, such as a monitor, screen, display, or the like, and can include a printer. The input device 308 can be, for example, a keyboard, mouse, touch screen, track ball, joystick, voice recognition system, or any combination thereof, or the like.
At least one imaging system 310 can be used including, but not limited to, MRI, computed tomography (CT), ultrasound, or other imaging systems. The imaging system 310 may communicate through a wired or wireless connection with the computing device 300 or, alternatively or additionally, a user can provide images from the imaging system 310 using a computer-readable medium or by some other mechanism.
The electrical stimulation system 312 can include, for example, any of the components illustrated in
The methods and systems described herein may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Accordingly, the methods and systems described herein may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Systems referenced herein typically include memory and typically include methods for communication with other devices including mobile devices. Methods of communication can include both wired and wireless (for example, RF, optical, or infrared) communications methods and such methods provide another type of computer readable media; namely communication media. Wired communication can include communication over a twisted pair, coaxial cable, fiber optics, wave guides, or the like, or any combination thereof. Wireless communication can include RF, infrared, acoustic, near field communication, Bluetooth™, or the like, or any combination thereof.
It has been found that users may fail to understand or accurately predict effects of particular stimulation parameters on a desired portion of patient tissue when programming stimulation parameters for the IPG 14 and ETS 20 (for example, in the operating room or in follow-up sessions). Accordingly, the stimulation system may fail to sufficiently stimulate, may completely fail to stimulate, or may adversely stimulate the patient tissue.
The present systems or methods facilitate the development of stimulation programs and the selection of stimulation parameters.
The user interface 400 also includes multiple selectable planes 406, 410. In at least some embodiments, the planes 406, 410 are each a bounded two-dimensional region which corresponds to a two-dimensional region in three-dimensional space around a lead in a patient (or a future position of a lead to be implanted in the patient). In at least some embodiments, the planes each intersect, border or are near or adjacent the lead representation 404. In at least some embodiments, the planes intersect a longitudinal axis or a surface of the lead representation 404.
In at least some embodiments, the user interface 400 also includes representations (not shown) of at least one anatomical or physiological feature. In at least some embodiments, these representations may be captured images or simulated images or models of the anatomical or physiological features.
The user interface 400 can permit a user to select any of the selectable planes 406, 410. In at least some embodiments, the user interface 400 may emphasize the selected plane 406. In at least some embodiments, the user interface 400 may simultaneously display at least one other plane 410 for potential selection by the user. In some embodiments, actions or selections taken with respect to one plane may limit or restrict actions that can be taken in another plane or may increase or provide additional actions that can be taken in the other plane. This other plane or planes may be planes that having the same orientation or a different (for example, perpendicular) orientation to the first plane. In some embodiments, selections or other actions taken in a plane other than the currently selected plane may be displayed in the corresponding plane.
In at least some embodiments, the user interface 400 also includes one or more controls for selection by the user. The controls permit the user to change between different planes 406, 410. As an example, in the illustrated embodiment, selection of the first user control 408 causes the user interface to display and, optionally, highlight a subsequent plane 410 in the set of planes. In at least some embodiments, selection by the user of the first user control 408 may cause the user interface 400 to remove the initial plane 406 from view and display the subsequent plane 410.
Selection by the user of a second user control 412 causes the user interface to display and, optionally, highlight a prior plane (not shown) in the set of planes. The selection by the user of the second user control 412, when following the selection of the first user control 408 by the user, may cause the user interface 400 to return to the plane 406.
In at least some embodiments, the interface 400 can include one or more controls for viewing a second, distinct set of planes. In at least some embodiments, each plane in the second set of planes may be orthogonal to each plane in the first set of planes. As an example, selection by the user of a third user control 414 may cause the user interface 400 to display at least one plane in a second set of planes as seen from a distal tip of the lead 404 (for example, the rounded tip of the lead representation 404 shown by
In at least some embodiments, the user interface 400 may, responsive to displaying the second set of planes, replace the user controls 408 and 412 with user controls to scroll through the second set of planes. In at least some embodiments, the user interface 400 may, responsive to a selection of either of the user controls 414 or 416 while the user interface 400 displays the second set of planes, return to displaying the first set of planes. It will be understood that instead of controls provided on the user interface 400, in at least some embodiments, such controls may be operated in response to hand gestures.
In at least some embodiments, the interface 500 may also define planes analogous to the plane 406 illustrated in
In at least some embodiments, the user interface 500 may include one or more potential-primitive controls 512. In at least some embodiments, the potential-primitive controls 512 may include at least one potential primitive 511, 513 for the user to place onto the interface. In the illustrated embodiment of
In at least some embodiments, the user interface 500 may include one or more primitive-designation controls. In the illustrated embodiment of
In at least some embodiments, the user interface 500 may include at least one primitive-movement control 518 to move a user-placed primitive within the interface in a direction or manner that corresponds to the user-operated primitive-movement control. User operation of these and other controls may be one or more of tap or click a control, press-and-hold or click-and-hold a control, or a hand gesture (for example, such as finger-drag in a predefined direction along at least one of a user-placed primitive or plane in the interface 500). Other controls, not shown, may pivot or rotate a user-placed primitive about at least one point (for example, a center of gravity of the primitive or a user-selected point). In some embodiments, controls may be used to change a primitive from one type (for example, a circle) to another type (for example, a hexagon or square).
In the illustrated embodiment of
In the illustrated embodiment of
In at least some embodiments, this grid 608 is analogous to the plane 406 illustrated in
In at least some embodiments, the user interface 600 may include at least one pixel-designation control such as a stimulation-designation control 612 and an avoid-designation control 614 that, when operated, cause a user-selected pixel to be designated for stimulation (for example, user-selected pixels 616) or designated to avoid stimulation (for example, user-selected pixels 618), respectively. These two different types of pixels can be distinguished visually or graphically using coloring, shading, patterns, or other graphical indicia or any combination thereof. In at least some embodiments, the user may select at least one pixel at a time (for example, via tapping, dragging a finger or cursor over, or circling at least one pixel in the grid of pixels 608). In at least some embodiments, the user may control a status of a user-selected pixel by operating at least one of the pixel-designation controls 612, 614 prior to or subsequent to user selection of the user-selected pixel.
In at least some embodiments, the interface 700 may also define planes analogous to the plane 406 illustrated in
In at least some embodiments, the user interface 700 may include at least one selectable object 716, 718 in the interface. In at least some embodiments, a selectable object may graphically represent at least one anatomical or physiological feature or some other region, area, or volume that is previously or contemporaneously defined. In at least some embodiments, a selectable object may include a captured image or a simulated image or a model of an anatomical or physiological feature (an entirety or a portion of the anatomical or physiological feature).
In at least some embodiments, the user interface 700 may include one or more object-designation controls such as a stimulation-designation control 710 and an avoid-designation control 712 that, when operated, may cause the user interface 700 to specify a selected selectable object as designated for stimulation (for example, the user-selected selectable object 718) or designated to avoid stimulation (for example, the user-selected selectable object 716), respectively. These two different types of designations, when applied to a selectable object, can be distinguished graphically or visually using, for example, differences in coloring, shading, patterns, or other graphical indicia or any combination thereof. In addition, selectable objects that have not been designated may also be graphically or visually distinguished. In at least some embodiments, the user may select at least one selectable object at a time (for example, via tapping, dragging a finger or cursor over, or circling at least one selectable object in the interface 700). In at least some embodiments, the user may operate at least one of the object-designation controls prior to or subsequent to user selection of at least one selectable object in the interface 700.
In at least some embodiments, the user interface 800 may include at least one value control for changing the current or voltage values on one or more of the electrodes 805. For example, the user may identify (for example, tap) one of the electrodes 805 of the lead representation 804 and subsequently operate the at least one value control.
Although the user interfaces 400, 500, 600, 700, and 800 of
The user interfaces 400, 500, 600, and 700 of
The user interfaces 400, 500, 600, 700, or 800 of
In at least some embodiments, at least one of the user interfaces 400, 500, 600, 700, or 800 of at least one of
In at least some embodiments, at least one of the user interfaces 400, 500, 600, 700, or 800 of at least one of
In steps 904a, 904b, or 904c, the user designates a desired stimulation region within the user interface. In some embodiments, only one of steps 904a, 904b, or 904c is performed. Steps 904a, 904b, and 904c can be considered alternatives to each other. In other embodiments, these steps 904a, 904b, 904c may be used in any combination. For example, the user interface may permit a user to specify a region using a combination of primitives (step 904b) and pixels in a grid (step 904a). As another example, the user interface may permit a user to specify an initial region using primitives (step 904b) and then translate that region into pixels on a grid and allow the user to modify the initial region to the desired region by selecting or deselecting pixels on the grid (step 904a). Any other combination of steps 904a, 904b, and 904c can be used. It will be recognized that the desired stimulation region may be a single, unified region or volume or may be divided in multiple, separate regions or volumes.
It will also be recognized that in any of these steps 904a, 904b, 904c, the designation may be repeated for multiple planes relative to the lead. In some embodiments, movement between the planes can be performed similar to that described with respect to user interface 400 of
In step 904a, the user designates a desired stimulation region by selecting pixels in one or more grids using, for example, the user interface 600 of
In step 904b, the user designates a desired stimulation region by placing one or more primitives using, for example, the user interface 500 of
In step 904c, the user designates a desired stimulation region by selecting one or more selectable regions using, for example, the user interface 700 of
It will be recognized that the user interface may also be used to specify a region to avoid stimulating, as described above with respect to user interfaces 500, 600, 700. One or more steps analogous to steps 904a, 904b, 904c (or any combination thereof) can be used to determine the region to avoid stimulating.
In some embodiments, one or more of the steps 904a, 904b, 904c may be repeated multiple times in an iterative manner to refine a stimulation region or to try different stimulation regions.
In step 906, the at least one computer processor generates at least one stimulation program based, at least in part, on desired stimulation region (and optionally a region to avoid stimulating) obtained using steps 904a, 904b, or 904c (or any combination thereof).
A stimulation program can be described by a set of stimulation parameters that produce the stimulation of the stimulation program. Stimulation parameters can include, but are not limited to, selection of electrode or electrodes to produce the stimulation, stimulation amplitude (total amplitude or individual amplitude for each electrode when multiple electrode are used to produce the stimulation), pulse width, pulse frequency, and the like. Some stimulation programs may also be more complex where the selection of electrodes may change during the program (for example, alternating between a first selection of electrodes and second selection of electrodes) or changes in amplitude, pulse width, pulse frequency, or the like. Also, some stimulation programs may include bursts of stimulation pulses with burst frequency and a pulse frequency.
The stimulation parameters can be used to calculate an estimated region of stimulation. The terms “stimulation field map” (SFM) and “volume of activation” (VOA) are often used to designate an estimated region of tissue that will be stimulated for a particular set of stimulation parameters. Any suitable method for determining the SFM/VOA can be used including those described in, for example, U.S. Pat. Nos. 8,326,433; 8,675,945; 8,831,731; 8,849,632; and 8,958,615; U.S. Patent Application Publications Nos. 2009/0287272; 2009/0287273; 2012/0314924; 2013/0116744; 2014/0122379; and 2015/0066111; and U.S. Provisional Patent Application Ser. No. 62/030,655, all of which are incorporated herein by reference. In some embodiments, a SFM/VOA may also be determined by methods other than calculation such as, for example, observations of stimulation effects, observations from internal or external sensors, imaging (e.g., MRI), or the like.
In at least some embodiments, the stimulation program is determined by selecting stimulation parameters that produce a SFM/VOA that matches the desired stimulation region within a predetermined degree or tolerance or that best matches the desired stimulation region. This may include, for example, selecting an initial set of stimulation parameters, calculating a SFM/VOA using those stimulation parameters, comparing that SFM/VOA to the desired stimulation region, and then refining the set of stimulation parameters in view of the comparison. This procedure can be iterated until a suitable set of stimulation parameters for a stimulation program are determined.
In addition, when a region to be avoided is also determined, the overlap between the region to be avoided and the calculated SFM/VOA may also be taken into account in refining the stimulation parameters. Moreover, in at least some embodiments, a suitable set of stimulation parameters will not overlap with the region to be avoided by at least some threshold amount, percentage, or other suitable measure of overlap.
In at least some embodiments, instead of calculating a SFM/VOA, stimulation parameters with an associated stimulation region (such as a SFM/VOA that has been previously calculated or otherwise determined) may be retrieved from an internal or external memory and compared to the desired stimulation region. For example, the system may use a database of stimulation parameters and associated stimulation regions to select the stimulation program (with its stimulation parameters) based on matching the database information with the desired stimulation region. Again, a determined region to be avoided may also be incorporated in this procedure for determination of the stimulation program.
In addition, in at least some embodiments, the user interface may provide controls by which the user may also manually alter one or more of the stimulation parameters for the stimulation program.
In at least some embodiments, the user interface may display the stimulation region for the stimulation program in relation to the desired stimulation region (and, optionally, the identified region to be avoided) to allow the user to visually observe the match between the regions.
In step 908, the at least one computer processor may deliver the stimulation program to an implantable pulse generator, ETS, or other device of an implantable electrical stimulation system. In at least some embodiments, the computer processor may initiate a signal that provides the implantable pulse generator, or other device, with the stimulation program for producing electrical stimulation to the patient in accordance with the stimulation program when selected.
In at least some embodiments, at least one of steps 902, 904a, 904b, 904c, 906, and 908 is skipped.
In step 1002, a desired stimulation region is received. The desired stimulation region may be based, at least in part, on at least one of user-selected pixels, a user-placed primitive, or a user-selected selectable object or any combination thereof as described above with respect to steps 904a, 904b, 904c. In some embodiments, a region to be avoided can also be designated. In some embodiments, multiple regions may be designated.
In some embodiments, the stimulation region (or region to be avoided) can be a volume defined by the user in using one plane or multiple planes. For example, the system may determine that the desired stimulation region extends from a designated region on a first plane to one or more other planes. In some embodiments, the system (automatically or under user direction) may uniformly extend the desired stimulation region around (partially or entirely) the lead to form a volume. For example, based on a ring electrode or a circumferentially elongated segmented electrode, the system may uniformly extend the desired stimulation region around the portion of the lead that the electrode covers. As another example, this same process may also be used based on a user-input command to uniformly employ segmented electrodes that are aligned with each other along the circumference of the lead. In at least some embodiments, this same processes may also be used (automatically or based on a user-input command) for longitudinally elongated electrodes or electrodes that are aligned with each other along the longitudinal length of the lead. In other embodiments, the system (automatically or under user direction) may decrease at least one dimension of the shape around the lead. In yet other embodiments, where a desired stimulation region is determined in more than one plane, the system may interpolate or estimate the stimulation volume between those planes. It will be understood that these same processes may also be used for a region to be avoided.
In at least some embodiments, the system may model the desired region or volume derived from the desired region using a predefined or stereotypical volume. For example, the stereotypical volume may include at least one three-dimensional shape such as, for example ovoid, ellipsoid, tube, Gaussian distributions, or Poisson distributions. The at least one three-dimensional shape may include a set or series of two-dimensional shapes such as, for example, Gaussian distributions, Poisson distributions, planar shapes, or cross-sections. For example, the two-dimensional shapes may be slices of the three-dimensional shapes. As another example, the two-dimensional shapes may include three or more shapes or planar faces that define outer boundaries of at least one closed volume. In at least some embodiments, the stereotypical volume may be defined by at least one of a center of mass, a major axis, a minor axis, a vertex, a mean in principal axes, a variance in principal axes, or spatial relationship to the lead representation.
In step 1004, a stimulation field model (SFM) or Volume of Activation (VOA) is determined based on the desired stimulation region. Any suitable method for determining the SFM/VOA can be used including those described in, for example, U.S. Pat. Nos. 8,326,433; 8,675,945; 8,831,731; 8,849,632; and 8,958,615; U.S. Patent Application Publications Nos. 2009/0287272; 2009/0287273; 2012/0314924; 2013/0116744; 2014/0122379; and 2015/0066111; and U.S. Provisional Patent Application Ser. No. 62/030,655, all of which are incorporated herein by reference. In particular, the system can calculate one or more SFMs/VOAs that approximate the desired stimulation region. Alternatively, the system may access a SFM library or database stored in memory internal or external to the system. In at least some embodiments, the library may, additionally or alternatively to SFMs, contain at least one other stimulation configuration such as, for example, stimulation parameters, electrode patterns, or the like.
In at least some embodiments, the system may select from one or more SFMs/VOAs that are calculated or retrieved based on how closely the SFM/VOA matches to the desired stimulation region. For example, searching for the closest match may include volume matching. It will also be understood, that for embodiments where a region to avoid stimulation is determined, the matching may also take a degree of overlap of each candidate SFM/VOA with the region to avoid into account (e.g., the system may require no overlap or no more than a particular degree or percentage overlap). In at least some embodiments, at least one of the desired region or the candidate SFM/VOA may be rotated for comparison to each other.
Any suitable metric may be used for determining the degree of matching between the desired stimulation region and an SFM/VOA. For example, a degree of matching may be determined using a distance metric. One example of a suitable distance metric is a sum of total differences between selected points on a surface or boundary of the desired stimulation region and analogous points on the SFM/VOA. The points may be uniformly or nonuniformly distributed or may be (or at least include) one or more critical points such as inflection/local maximum/local minimum points on the surface or boundary, surface or boundary points associated with lines radiating from a center or center of mass of the region or volume, or special points associated with particular shapes (for example, elliptical foci).
Another example of suitable distance metric represents the region or volume, as well as the SFM/VOA, by one or more m×n matrices of values where each matrix corresponds to a two-dimensional region of space (similar to the grid 608 in
As another distance metric, the region or volumes, as well as the SFM/VOA, are represented by one or more m×n matrices of values where each matrix corresponds to a two-dimensional region of space (similar to the grid 608 in
When the desired region of stimulation and SFM/VOA have similar shapes, other metrics can be used based on those shapes. For example, a distance metric may be a spatial distance between center of mass coordinates of the desired stimulation region and the SFM/VOA, a difference in volumes or a weighted difference in axes (e.g., length cubed to represent contributions of axes to volume, or length squared to target area), differences in cross-sectional area contours, or the like.
In some embodiments, an SFM/VOA may be selected from a number of different SFMs/VOAs based on having a most favorable distance metric. In some embodiments, a SFM/VOA may be selected because it has a distance metric that is below a threshold value. Other methods of selection may also be used. In addition, where a region to avoid stimulation is also determined, the selection may also take into account the degree of overlap with the region to avoid (e.g., the system may require no overlap or no more than a particular degree or percentage overlap) and may reject an otherwise acceptable SFM/VOA based on the unacceptable overlap with the region to avoid.
In step 1006, the system generates stimulation program based on the determined SFM/VOA. Generally, the SFM/VOA is calculated or associated with a particular set of stimulation parameters.
In any of the systems and methods described above, when the computing device 300 generates the stimulation program, the computing device 300 may communicate at least one of the set of stimulation parameters or the stimulation program to the IPG 14, the ETS 20, or another device.
It will be understood that the system can include at least one of the methods described hereinabove with respect to
The methods, systems, and units described herein may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Accordingly, the methods, systems, and units described herein may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. The methods described herein can be performed using any type of processor or any combination of processors where each processor performs at least part of the process.
It will be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations and methods disclosed herein, can be implemented by computer program instructions. These program instructions may be provided to a processor to produce a machine, such that the instructions, which execute on the processor, create means for implementing the actions specified in the flowchart block or blocks disclosed herein. The computer program instructions may be executed by a processor to cause a series of operational steps to be performed by the processor to produce a computer implemented process. The computer program instructions may also cause at least some of the operational steps to be performed in parallel. Moreover, some of the steps may also be performed across more than one processor, such as might arise in a multi-processor computer system. In addition, at least one process may also be performed concurrently with other processes, or even in a different sequence than illustrated without departing from the scope or spirit of the invention.
The computer program instructions can be stored on any suitable computer-readable medium including, but not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (“DVD”) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a computing device.
The above specification provides a description of the structure, manufacture, and use of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 62/444,724, filed Jan. 10, 2017, which is incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20180193655 A1 | Jul 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62444724 | Jan 2017 | US |
